Henlius Trastuzumab Begins its Journey to Saudi Arabia
· HANQUYOU is poised to be the first Chinese monoclonal antibody to enter the Middle Eastern market, further expanding its global presence.
· HANQUYOU was approved in more than 40 countries and regions around the world.
· With the first shipment to the Middle East, Henlius has realized commercialized supply across China, Europe, Southeast Asia, Latin America, and now the Middle East.
On June 6, 2024, Henlius' independently developed and produced product, HANQUYOU (trade name: HERCESSI™ in the U.S. and Zercepac® in Europe), left Henlius’ Xuhui Facility, heading to Saudi Arabia, with the expectation of being the first Chinese monoclonal antibody (mAb) biosimilar to hit the market in the Middle East. This milestone signifies the company’s first commercialized delivery to the Middle East and North African (MENA) countries and is a testament to the exclusive commercial partnership formed with the international partner Intas and its subsidiary Accord, covering parts of Europe, North America, certain areas of MENA, and CIS countries.
Mr. Jason Zhu, Executive Director, Chief Executive Officer and Chief Financial Officer of Henlius stated, “The launch of HANQUYOU to Saudi Arabia, accelerating its expansion to the markets of the MENA, and beyond to the global market, is not only a reflection of Henlius’ globalization strategy but also a solid demonstration of our commitment to providing patients worldwide with quality and affordable biologics. We look forward to working with our global business partners to bring the beacon of hope to every corner of the world that needs it.”
HANQUYOU (trade name: HERCESSI™ in the U.S. and Zercepac® in Europe) is a China-developed mAb biosimilar approved in China, the European Union (EU) and U.S. It is now approved in more than 40 countries and regions including the U.S., United Kingdom (UK), France, Germany, Switzerland, Australia, Finland, Spain, Argentina, Saudi Arabia, and Thailand, covering Asia, Europe, Latin America, North America, and Oceania, and it is reimbursed nationally in countries and regions including China, the UK, France and Germany. To date, HANQUYOU has benefited over 190,000 patients.
The development, manufacturing and the quality management system of HANQUYOU (trade name: HERCESSI™ in the U.S. and Zercepac® in Europe) are in line with global standards. The Xuhui Facility, from which HANQUYOU has been shipped, is the first plant in China that has obtained dual GMP certifications from China and Europe to manufacture self-developed antibodies. Also, the facility has successfully passed the on-site inspection conducted by NMPA, the European Medicines Agency (EMA), the EU qualified person, and PIC/S members Indonesia Food and Drug Administration (BPOM) and Brazilian National Health Surveillance Agency (ANVISA), as well as multiple international business partners. In 2023, the manufacturing site and facility where HANQUYOU is manufactured underwent and successfully passed the Pre-License Inspection (PLI) by the FDA. The success of the FDA PLI, as well as the previous GMP certifications from China and EU regulatory agencies, makes Henlius a biopharmaceutical company GMP-certificated by China, the EU and U.S. for the manufacturing of self-developed antibody drugs.
